And will generics be fully substitutable, as their makers hope?
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O) could have the first substitutable generic version of GlaxoSmithKline's (GSK.
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"They're not substitutable," CEO Lawrence Kurzius told Reuters in an interview.
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But one thing is certain, he said: "They won't be easily substitutable."
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In today's economy, with increasing skill and knowledge complexity, workers are not easily substitutable.
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Non-cognitive skills and abstract reasoning are valuable as they are not directly substitutable by robotics.
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That is a worry for other firms hoping to sell substitutable generic Advair in the big U.S. market.
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"It all matters, especially when you're dealing with destinations that are somewhat substitutable," said Mr. Kaplan, of Airline Weekly.
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Adrenaclick is on the market now, but isn't considered "therapeutically equivalent" to EpiPen, which would make it more easily substitutable.
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The U.S. Food and Drug Administration is due to decide whether to approve the first substitutable Advair generic, from Mylan, by March 28.
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"All of our medicines are substitutable with generic and therefore patients should be able to access a range of suitable alternatives," Nakibur said.
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When the controversy over the price of the EpiPen exploded late last summer, many consumers asked why there was no substitutable generic version available.
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Just this week, a new competitor to the EpiPen was cleared to enter the U.S. market: a directly substitutable generic copy from Israeli drugmaker Teva Pharmaceuticals.
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But with another substitutable Advair generic from Hikma potentially winning a green light by May 10, GSK reiterated that generic Advair could still dent full-year profits.
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It predicts that EPS, in constant currencies, will be flat to slightly lower in 2017, if substitutable Advair generics arrive in the United States by mid-year.
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Teva's product promises to grab some of this business in asthma but the bigger threat will come from fully substitutable generic copies of Advair, which are still pending approval.
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Water is unique in being a resource that is continually necessary for survival, non-substitutable with other resources or money, and practically constrained by the cost of moving and cleaning it.
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"You're seeing a lot more snacking alternatives or substitutable occasions that is taking people away from traditional sugar confection and also that everyday kind of chocolate purchase," said UBS analyst Steven Strycula.
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GSK has told the market that core earnings per share, in constant currencies, will be flat to slightly lower in 2017, if substitutable Advair generics arrive in the United States by mid-year.
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The company said in February that core earnings per share, in constant currencies, would be flat to slightly lower in 2017, if substitutable Advair generics arrive in the United States by mid-year.
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Teva's version of GSK's blockbuster medicine, called AirDuo RespiClick, is not directly substitutable for Advair and is only approved for asthma, while Advair is also widely used for chronic obstructive pulmonary disease (COPD).
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GSK said EPS, in constant currencies, were set to be flat to slightly lower in 2017, if substitutable generic copies of Advair arrive in the United States by mid-year, as most analysts expect.
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The FDA guidance says that generic copies with some design differences may be approved as substitutable products, as long as those differences don't affect patients' ability to use the product the way it's intended.
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"Nobody wants to kill the market," said Rajiv Malik, president of Mylan, which will have the first commercial Advair copy, assuming U.S. regulators approve its substitutable generic device by a target date of March 2300, 20203.
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"The majority of biosimilars are not expected to be deemed interchangeable by the FDA, when the majority of generics generally are therapeutically equivalent and substitutable," said Thomas Felix, medical director of global regulatory affairs and safety at Amgen.
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The U.S. Food and Drug Administration (FDA) had been due to decide by March 28 whether to approve the first substitutable generic copy of the two-part drug for asthma and chronic lung disease, made by generics firm Mylan.
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"When the jobs these guys filled go away, it's not clear there is something new and substitutable any time soon," said Jason Faberman, an economist at the Federal Reserve Bank of Chicago who has studied the skills gap issue.
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That should not come as a huge surprise to investors, since GSK's own long-term guidance already assumes U.S. Advair sales could fall to 300 million pounds ($435 million) in 2020, from 1.97 billion in 2014, if substitutable generics are launched.
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The authors go on to argue that America benefitted greatly too, by making the familiar argument that foreign workers are not all that substitutable for domestic ones—in other words, that migrants make possible work that would not otherwise happen.
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Another thesis is that, in the long term, this debt crisis was caused when the Puerto Rican economy clashed after U.S. authorities removed the industrial incentives provided to Puerto Rico under section 28503 of the federal tax code without any substitutable economic strategy.
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The Fed chair said financial firms have a preference for holding reserves when planning for stress scenarios, and that central bank officials are considering changes to address situations when Treasuries and reserves should be "fully substitutable," in a letter to Senator Sherrod Brown.
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Just four days before Walmsley moves into the top job on April 1, U.S. regulators could approve the first substitutable generic version of GSK's inhaled lung drug Advair, which has raked in more than a $1 billion in sales every year since 2001.
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The Fed chair said financial firms have a preference for holding reserves when planning for stress scenarios, and that central bank officials are considering changes to address situations when Treasuries and reserves should be "fully substitutable," in a letter to Senator Sherrod Brown.
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The FDA issued guidance in November 2017 to try to make it easier for generic copies of complex medicines like the EpiPen to reach the market, saying some design differences may be approved as substitutable products, as long as those differences don't affect patients' ability to use the product the way it's intended.
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The drug has beaten rivals in fighting relapsing remitting MS and could become the only approved drug for primary progressive MS. The picture is a lot less certain for Britain's GSK as it faces the threat of cut-price competition from Mylan, which hopes to secure approval for the first substitutable generic copy of GSK's top-selling Advair lung drug by March 28.
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The study also found that the arrangement works best for relatively non-substitutable goods, like cosmetics and brand fashions.
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Both Stern (p. 163) and the IPCC Reports after > 1995 take a multi-criteria approach rather than a narrowly monetary one and > question cost-benefit analysis. This is one reason for the intemperate > response from some traditional economists to the Stern Review Eric Neumayer (2007) of the London School of Economics thought that the Review could have argued for emission reductions based on the non-substitutable loss of natural capital. Neumayer argued that the real issue is the non- substitutable loss of natural capital, that is to what extent climate change inflicts irreversible and non-substitutable damage to and loss of natural capital.
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London, Routledge. In conventional cost-benefit analysis, biodiversity and ecosystem services that are not valued as losses are difficult to quantify. Neumayer argues that the real issue is non-substitutable loss of natural capital; to what extent climate change inflicts irreversible and non-substitutable damage to and loss of natural capital.Neumayer (2007) A missed opportunity: the Stern review on climate change fails to tackle the issue of non-substitutable loss of natural capital For example, it would be difficult to quantify the loss of coral reefs, biodiversity loss, or species extinction. Dietz points out that in many Integrated Assessment Models (IAMs), health and ecosystem impacts are not included because the monetary valuation of these impacts is “speculative and uncertain”.
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The more similar their relations are with other people i.e. the more substitutable they are with one another, the more they will copy what the other is doing, if it makes them look better, to stay ahead of competition.
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The components of a composite index are called 'substitutable' if a deficit in one component may be compensated by a surplus in another (e.g., a low value of “Proportion of people who have participated in religious or spiritual activities” can be offset by a high value of “Proportion of people who have participated in meetings of cultural or recreational associations” and vice versa). Similarly, the components of a composite index are called 'non-substitutable' if a compensation among them is not allowed (e.g., a low value of “Life expectancy at birth” cannot be offset by a high value of “GDP per capita” and vice versa).
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However, stipulations exist to ensure pools do not function anti-competitively. As required by the DOJ, patents in the pool must be essential, non-substitutable and the owners must maintain the right to individually license their patents. In addition, the DOJ may monitor the royalty rates collected by the firm.
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This theory is also called the segmented market hypothesis. In this theory, financial instruments of different terms are not substitutable. As a result, the supply and demand in the markets for short-term and long-term instruments is determined largely independently. Prospective investors decide in advance whether they need short-term or long-term instruments.
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It is also important to note that strong sustainability does not share the notion of inter-changeability. Since the nineties, there has been an ardent debate on the substitutability between natural and human-made capital. While "Weak Sustainability" supporters mainly believe that these are substitutable, "Strong Sustainability" followers generally contest the possibility of inter- changeability.
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A UML Component with provided and required interfaces A component in the Unified Modeling Language represents a modular part of a system that encapsulates the state and behavior of a number of classifiers. Its behavior is defined in terms of provided and required interfaces,OMG (2008). OMG Unified Modeling Language (OMG UML), Superstructure, V2.1.2 is self- contained, and substitutable.
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Rate transparency had elevated the importance of incorporating market positioning against substitutable alternatives. IHG recognized that when a competitor changes its rate, the consumer's perception of IHG's rate also changes.Cross, R., Higbie, J. and Cross, D. (2009) Revenue management's renaissance: a rebirth of the art and science of profitable revenue generation. Cornell Hospitality Quarterly 50: 56-81.
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Human capital is substitutable, but not transferable like land, labor, or fixed capital. Some contemporary growth theories see human capital as an important economic growth factor. Further research shows the relevance of education for the economic welfare of people. Adam Smith defined four types of fixed capital (which is characterized as that which affords a revenue or profit without circulating or changing masters).
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Technological innovation implies that humans are able to use technology to fill the gaps in situations where resources are imperfectly substitutable. A market-based theory depends on proper pricing. Where resources such as clean air and water are not accounted for, there will be a "market failure". These failures may be addressed with Pigovian taxes and subsidies, such as a carbon tax.
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They have a verbal or written collusion agreement between them. Firms operating in a market of low product differentiation might not coordinate with others, which increases the incentive to cheat the collusion agreement. On the contrast, even by slightly lowering the prices, a firm can capture large fraction of the market and obtain short term profits with highly substitutable products.
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The Mazziotta–Pareto index (MPI) is a composite indexA composite index is a mathematical combination (or aggregation as it is termed) of a set of indicators that represent the different dimensions of a phenomenon to be measured (OECD, 2008OECD (2008). Handbook on Constructing Composite Indicators. Methodology and user guide. OECD Publications, Paris.) for summarizing a set of individual indicators that are assumed to be not fully substitutable.
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See the Library of Congress website and search H.R. 1548 in 111th Congress Session. Since 2004 the FDA has held a series of public meetings on biosimilars. The FDA gained the authority to approve biosimilars (including interchangeables that are substitutable with their reference product) as part of the Patient Protection and Affordable Care Act signed into law by President Obama on March 23, 2010.
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Both of these industries have highly specialized labor conditions and are generally not substitutable. According to a 2020 review of the existing literature on monopsony in labor markets, there is some evidence of monopsony power in higher income industries due to contractual limitations (non-competes for example) though the author notes that the large majority of economists do not ascribe notable monopsony effects to labor markets.
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The conceptualization of nature as understood by ecological economics is that manufactured capital and natural capital are not exclusive or substitutable, but rather complementary. PES as understood by ecological economics comprises three schematic components. The first surrounds the importance of the economic incentive. This idea concerns the relative weight an economic incentive may carry when understood in relation to social, moral, or other non-economic incentives.
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Mexico cited several cases wherein 'like product' was defined broadly to include products that "though not 'like' the imported product, are nonetheless commercially interchangeable or substitutable for it". In this case, that would have meant "US-made plastic brooms were 'like' the imported broomcorn brooms under investigation", and therefore the impact of US imports of Mexican broomcorn brooms had a negligible effect on the overall US broom market.
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Agents balance their portfolios among domestic money and bonds, and foreign currency and bonds. Whenever aggregate economic conditions change, agents adjust their portfolios to a new equilibrium, based on a variety of considerations, i.e., wealth, tastes, expectation, etc.. Thus, these actions to balance portfolios will influence exchange rates. ;The expectations or signaling channel :Even if domestic and foreign assets are perfectly substitutable with each other, sterilized intervention is still effective.
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Tafamidis was approved for medical use in the European Union in 2011, and in Japan in 2013. It was initially rejected in the United States in 2012, then approved in 2019. In the United States two preparations, tafamidis meglumine and tafamidis, were approved for the treatment of transthyretin mediated cardiomyopathy (ATTR-CM). The two preparations have the same active moiety, tafamidis, but they are not substitutable on a milligram to milligram basis.
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For the goal valence mechanism, Fox and Hoffman (2002) describe valence as "the extent of attractiveness or desirability of the goal." Goals that are perceived to be very valuable, defined as those that meet the needs of the individual, are high valence. Goals with high positive valence are not easily substitutable, meaning they cannot be easily replaced by another goal. An individual is more likely to persist to complete a goal that cannot be substituted for another goal.
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A currency or monetary union is a multi- country zone where a single monetary policy prevails and inside which a single currency or multiple substitutable currencies, move freely. A monetary union has common monetary and fiscal policy to ensure control over the creation of money and the size of government debts. It has a central management of the common pool of foreign exchange reserves, external debts and exchange rate policies. The monetary union has common regional monetary authority i.e.
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Retrieved on 10 July 2016. On May 2, 2007, GPhA's then-Chairman Bruce Downey testified before the House Energy and Commerce Committee Subcommittee on Health, urging Congress to pass legislation giving FDA the authority to approve biosimilars. Congress created an approval pathway for biosimilars (including interchangeables that are substitutable with their reference product) with passage of the Biologics Price Competition and Innovation Act, part of the Patient Protection and Affordable Care Act signed by President Obama on March 23, 2010.
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The T6O18 is the basic ring structure, where T is usually Si4+, but substitutable by Al3+ or B3+. Tourmalines can be subgrouped by the occupancy of the X site, and from there further subdivided by the chemistry of the W site. The Y and Z sites can accommodate a variety of cations, especially various transition metals; this variability in structural transition metal content gives the tourmaline group greater variability in colour. Other cyclosilicates include beryl, Al2Be3Si6O18, whose varieties include the gemstones emerald (green) and aquamarine (bluish).
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In logic, extensionality requires "two formulas which have the same truth-value under any truth-assignments to be mutually substitutable salva veritate in a sentence that contains one of these formulas." Put simply, objects that have the same external properties are equal. This principle, applied to decision making, suggests that making a decision in a problem should not be affected by how the problem is described. For example, varied descriptions of the same decision problem should not give rise to different decisions, due to the extensionality principle.
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Frege proposed to resolve this puzzle by postulating a second level of meaning besides reference in the form of what he called sense: a difference in the mode of presentation or the way an object can be "given" to us. Thus 'Hesperus' and 'Phosphorus' have the same reference, but differ in sense because they present Venus in different ways. The second puzzle concerns propositional attitude reports, such as belief reports. Ordinarily, coreferring names are substitutable salva veritate, that is, without change in truth value.
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Within academia, the location of media economics research varies depending upon the tradition and history of the institution. In some universities it is located in schools of business or economics, whereas in others it is located in communication, media or journalism schools (or departments). The term "cultural economics" is sometimes used as a synonym for media economics but they are not substitutable. Cultural economics includes a wide variety of activities that do not necessarily involve mediated dissemination such as museums, symphonies, operas, and festivals.
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This would eventually have the effect, of suppressing the operation of mechanism that facilitate, bring with them, and hopefully determine its eventual destiny. However, Foucault notices specific problems began to emerge for neo-liberalism, not only specific to neo- liberalism was how to incorporate civil society, political power; and Homo oeconomicus into a non-substitutable, irreducible atom of interest. Foucault makes the starting point of his investigations into this process from the 18th century where Homo oeconomicus has to be integrated into the system of which he is a part.The Birth of Biopolitics pp.
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The Act also allows drugs listed as preferred to be eligible for "sealed non-transparent rebates" to occur from the manufacturer of the drug to the state agency. These are legally sanctioned kickbacks in which the public by federal law does not have a right to know the amount of the rebate below the average wholesale price (AWP). In cases where "no sufficient evidence exists" a drug is any less safe, (according to the evidence report) the drug is declared "substitutable", and eligible for placement on the PDL, and for the supplemental rebate program.
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In addition, since LVDS requires a fixed clock frequency that concentrates spectrums, the interface systems have to minimize electromagnetic interference. Furthermore, since FPD-Link mainly uses electrical digital signaling between zero volts (the ground level) and 1.2 volts based on its standard, it became a significant constraint of designing higher density LSIs. Under such circumstances, many substitutable interfaces such as DVI, HDMI, DisplayPort, and V-by-One HS are offered and adopted widely. DVI and HDMI have widely penetrated as external interfaces between equipments since DVI and HDMI can adjust skews.
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Kosuth's thematization of semantic congruities and incongruities can be seen as a reflection of the problems which the relations between concept and presentation pose. Kosuth uses the related questions, "how meanings of signs are constituted" and "how signs refer to extra-lingual phenomena" as a fundament to discuss the relation between concept and presentation. Kosuth tries to identify or equate these philosophical problems with the theory of art. Kosuth changes the art practice from hand-made originals to notations with substitutable realizations, and tries to exemplify the relevance of this change for the theory of art.
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In a February 2008 letter, Castro announced that he would not accept the positions of President of the Council of State and Commander in Chief at that month's National Assembly meetings,; ; remarking, "It would betray my conscience to take up a responsibility that requires mobility and total devotion, that I am not in a physical condition to offer". On 24 February 2008, the National Assembly of People's Power unanimously voted Raúl as president. Describing his brother as "not substitutable", Raúl proposed that Fidel continue to be consulted on matters of great importance, a motion unanimously approved by the 597 National Assembly members.
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Jeremy L. Neufeld, The Myth of the Unskilled Diversity Visa Immigrant, Niskanen Center (November 20, 2019). There is no support in the economics for the assertion that immigrants suppress wages and take jobs from Americans; to the contrary, research by Lewis and several other economists of migration shows that diverse and low-skilled immigrants lift the wages of native-born workers, as those immigrants are less substitutable to native-born workers. Charles Kenny, an economist at the Center for Global Development, noted that research by Harvard economist Alberto Alesina found that countries with a higher share of foreign-born populations tended to have more innovation and higher incomes.
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In "Art after Philosophy," Kosuth provoked a confrontation with the formal criticism of Clement Greenberg and Michael Fried. Both exposed the concept of the art work as a non-substitutable instance realized by an artist who follows no other criteria than visual ones. They defined this concept as the core of modernism. In the sixties, Greenberg's and Fried's modernist doctrine dominated the American discussions on art; meanwhile, the artists Allan Kaprow, Dick Higgins, Henry Flynt, Mel Bochner, Robert Smithson and Joseph Kosuth wrote articles on art exemplifying a pluralistic anti- and post-modernist tendency which gained more influence at the end of the sixties.
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This argument appears to be invalid: even if (3) and (4) are true, (5) could be false. If Alex is not aware that Hesperus and Phosphorus are the same planet, then it seems that he could believe that Hesperus is visible in the evening while rejecting the claim that Phosphorus is visible in the evening (perhaps he thinks Phosphorus, the morning star, is only visible in the morning). The principle that coreferring names are substitutable salva veritate thus appears to fail in the context of belief reports (and similarly for other propositional attitude reports). Frege again proposed to solve this problem by appeal to his distinction between sense and reference.
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These categories are analyzed according to specific classifications, including critical, non- renewable/nonsubstitutable, non-renewable/substitutable, and renewable natural capital. The Sustainable Cost Approach results in a notional amount on the income statement that quantifies the organization's failure to "leave the biosphere at the end of the accounting period no worse off than it was at the beginning of the accounting period". In other words, this amount represents how much it would cost an organization to return the biosphere to its natural state at the beginning of the accounting period. The Resource Flow/Input- Output Approach attempts to report the resource flows of the organization.
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Ottaviano's and Peri's thinking about the effects of immigration on natives' wages turns around the notion that natives and foreigners are inherently imperfectly substitutable even within the same skill group. Using this framework, they show that immigration to the U.S. in 1990-2006 had small negative short-run effects on native high school dropouts (-0.7%) and average wages (-0.4%), while raising the wages of native high school dropouts and average native wages in the long run by 0.3% and 0.6%, respectively, but depressing the long-run wages of previous immigrants by 6.7%.Ottaviano, G.I.P., Peri, G. (2005). Rethinking the Gains from Immigration: Theory and Evidence from the US. NBER Working Paper Series, No. 11672.Ottaviano, G.I.P., Peri, G. (2008).
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Their thinking about the effects of immigration on natives' wages turns around the notion that natives and foreigners are inherently imperfectly substitutable even within the same skill group. Using this framework, they showed that immigration to the U.S. in 1990-2006 had small negative short-run effects on native high school dropouts (-0.7%) and average wages (-0.4%), while raising the wages of native high school dropouts and average native wages in the long run by 0.3% and 0.6%, respectively, but depressing the long-run wages of previous immigrants by 6.7%.Ottaviano, G.I.P., Peri, G. (2005). Rethinking the Gains from Immigration: Theory and Evidence from the US. NBER Working Paper Series, No. 11672.
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In a 2018 paper, "In Search of the Armington Elasticity", Feenstra and co-authors address the long-standing issue in international trade of measuring the degree of substitution between goods imported from different countries, versus the degree of substitution between imported and domestically-produced goods. They make use of a novel dataset to estimate both elasticities and assess the "rule of two", under which foreign goods are twice as substitutable for each other as they are for domestically-produced goods. They confirm that result, though with confidence intervals that are not that tight. Feenstra has also conducted research on the impact of China’s joining the WTO on its exports– the so- called China shock – and on employment in the United States and elsewhere.
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Deforestation of native rain forest in Rio de Janeiro City for extraction of clay for civil engineering (2009 picture). The sustainable development debate is based on the assumption that societies need to manage three types of capital (economic, social, and natural), which may be non-substitutable and whose consumption might be irreversible. Leading ecological economist and steady-state theorist Herman Daly, for example, points to the fact that natural capital can not necessarily be substituted by economic capital. While it is possible that we can find ways to replace some natural resources, it is much more unlikely that they will ever be able to replace eco-system services, such as the protection provided by the ozone layer, or the climate stabilizing function of the Amazonian forest.
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A number of high-profile players in the health care informatics field are showing interest in and experimenting with FHIR, including CommonWell Health Alliance and SMART (Substitutable Medical Applications, Reusable Technologies). In 2014, the U.S. Health IT Policy and the Health IT Standards committees endorsed recommendations for more public (open) APIs. The JASON task force report on "A Robust Health Data Infrastructure" says that FHIR is currently the best candidate API approach, and that such APIs should be part of stage 3 of the "meaningful use" criteria of the U.S. Health Information Technology for Economic and Clinical Health Act. Open source implementations of FHIR data structures, servers, clients and tools include reference implementations from HL7 in a variety of languages, SMART on FHIR and HAPI-FHIR in Java.
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The RBV argues that resources that are rare, valuable, inimitable, and non-substitutable are considered to be the source of sustained competitive advantage. The CBV complements with the RBV in that it does not emphasize possession of superior strategic resources as a necessary condition for the firm’s competitive advantage. Instead, the CBV underscores the use of multiple sources of open or generic resources – resources which when used in a creative composition may yield a competitive edge to the firm, at least temporarily. Also, the CBV points out that composition process is a distinct competence and critical capability that is valuable, heterogeneous, and not always easy to imitate. Resource management is the comprehensive process of structuring the firm’s resource portfolio, bundling the resources to build capabilities, and leveraging those capabilities with the purpose of creating and maintaining value for customers and owners.
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Tomato paste is traditionally made in parts of Sicily, southern Italy and Malta by spreading out a much-reduced tomato sauce on wooden boardsLyn Rutherford, Patrick McLeavey -The Book of Antipasti - Page 8 1992 "Sun-dried tomato paste — with a richer flavor than ordinary tomato paste, sun-dried tomato paste is a really useful cupboard ingredient." that are set outdoors under the hot August sun to dry the paste until it is thick enough, when it is scraped up and held together in a richly colored, dark ball. Today, this artisan product is harder to find than the industrial version (which is much thinner).Bill Pritchard, David Burch Agri-Food Globalization in Perspective 2003 -Page 183 "Northern Italy is potentially vulnerable to the restructuring of pan-European supply chains because its key output, industrial grade tomato paste, is a standard product readily substitutable from a number of production areas." Commercial production uses tomatoes with thick pericarp walls and lower overall moisture; these are very different from tomatoes typically found in a supermarket.
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